MAUDE Adverse Event Report: COVIDIEN EPUMP 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 772055

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that the feeding set had long gaps of air in the tubing line between the formula.There was no patient harm.

Manufacturer Narrative

Additional information: h1, h2, h3, h6.Investigation summary: the customer reported that the feeding set had long gaps of air in the tubing line between the formula.A device history record review was unable to be completed as the reported lot number was unknown/invalid.Trend analysis of the reported failure was completed and a trend was not identified.The reported device was returned for evaluation.Visual inspection and functional testing performed confirmed the reported issue of air in the line.An investigation has been initiated to determine the root cause of this device failure.The root cause and conclusion of the confirmed device failure will be documented within the investigation.This product issue will continue to be monitored and trended.

• Brand Name: EPUMP 500ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11102129
• MDR Text Key: 224590305
• Report Number: 1282497-2020-09824
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 772055
• Device Catalogue Number: 772055
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/30/2020
• Patient Sequence Number: 1